Drug License in India

Drug and cosmetic industry serve the interest of a larger community, an Act to regulate its manufacture, import, sale, and distribution was passed in the year 1940. The drug license rules under the Drug and Cosmetic Act, 1940 are as follows:

• • The person who wishes to acquire a drug license must have at least four years of practical experience in the distribution of drugs.
• • A licensee can only manufacture any drug under the personal supervision of a registered pharmacist.
• • Further, the retailer of the drug must keep a record in the register at the time of drug supply.
• • The licensee ought not to sell or stock any drug after its expiry date.
• • Also, the drugs can be sold to a minor (below 18 years).
• • The medicine in a retail shop to cure animals should have a tag of “Not for human use, for treatment of animals only.”
• • Every drug license holder should maintain a purchase record of the drugs sold by retail or intended for sale.
• • Moreover, the act prohibits a licensee from storing any drugs at his premises which were intended for free sample distribution to a medical profession.
• • Any medicine prescribed by a registered medical practitioner must be under the inspection of a registered pharmacist before retail supply.
• • The drugs categorized in Schedule X or Schedule H has a validity of two years. Therefore, it should be supplied to all registered entities like dispensaries, nursing homes, Medical Practitioners and hospitals only in regards to a signed written order.

Note: If you have stored any expired drugs to claim a rebate from the Income Tax, then it will not be considered an offence under the Drug and Cosmetic Act, 1940, unless not intended for sale.